Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-7
Recalled June 17, 2026 · FDA recall D-0583-2026 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit · FDA Class II
Units
359,676 bottles
Sold at
Nationwide within the United States
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Manufacturer(s)
Breckenridge Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →